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Vistagen Receives FDA “Study May Proceed” Letter Under its Investigational New Drug Application for PH10 to Treat Major Depressive Disorder
Vistagen to conduct small U.S. Phase 1 trial with newly optimized formulation of PH10 in Q1 2023 to confirm favorable safety profile from three previous
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nVistagen to conduct small U.S. Phase 1 trial with newly optimized formulation of PH10 in Q1 2023 to confirm favorable safety profile from three previous clinical trials and to facilitate Phase 2B development of PH10 for major depressive disorder\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen, (NASDAQ: VTGN) a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA). The letter greenlights a U.S. Phase 1 clinical trial under Vistagen’s newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD). The small Phase 1 trial (n=12) will involve the Company’s newly optimized formulation of PH10 and is intended to both confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD, and facilitate Vistagen’s plans for Phase 2B development of PH10 as a stand-alone treatment for MDD.\n\n“People living with major depressive disorder urgently need new and differentiated therapies – we are committed to addressing that need. The FDA’s clearance to advance our clinical program for PH10 in the U.S. is another important milestone for our company,” stated Shawn Singh, Chief Executive Officer of Vistagen. “With our newly optimized formulation and manufacturing process for PH10 in place, the FDA’s greenlight will now enable us to first confirm its favorable safety profile in a small Phase 1 study next quarter and then seek consensus with the FDA regarding our Phase 2B development plan for PH10 in major depressive disorder.”\n\nAt a 6.4 μg dose administered intranasally twice daily for 8 weeks, PH10 significantly reduced depressive symptoms as early as one week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared to placebo (p = 0.022) in a small (n=30) exploratory randomized, double-blind, placebo-controlled parallel design Phase 2A study in MDD. PH10 was well-tolerated and did not cause psychological side effects (such as dissociation or hallucinations) or other safety co...